Catalog Number 0684-00-0575 |
Device Problem
Backflow (1064)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2018 |
Event Type
malfunction
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Manufacturer Narrative
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The product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy there was blood backed up in the catheter and it stopped augmenting.A new iab was used to continue therapy.There was no reported injury to the patient.
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy there was blood backed up in the catheter and it stopped augmenting.A new iab was used to continue therapy.There was no reported injury to the patient.
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Manufacturer Narrative
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Additional information: added lot #, serial #, and expiration date.Added initial reporter's email address.Added manufacture date.Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter and within the stat-gard sleeve.No blood was observed inside the iab catheter.A clear fluid was observed inside the returned iab catheter.One kink was observed on the catheter tubing near the y-fitting approximately 76.2cm from the iab tip.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.We were unable to perform a pump test due to the iab catheter returned condition.An evaluation of the product was unable to duplicate the reported problem.The product performed according to specification.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
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Search Alerts/Recalls
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